Join our client as QA Manager of Operations and play a key role in maintaining top-tier quality standards!
Proclinical is seeking a QA Manager to join the QA Operational Unit supporting drug development, production, and lifecycle management. This role focuses on ensuring compliance with cGMP standards and internal quality guidelines. The position is based in Basel and requires on-site presence.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- Lead and coordinate complex projects and processes within the QA Operational Unit.
- Provide quality oversight and support for GMP-related activities within Technical Research and Development (TRD).
- Prepare, review, and approve documentation, including batch records, certificates of analysis, SOPs, and risk assessments.
- Authorize the release of batches, materials, and components for clinical trials in accordance with applicable SOPs.
- Oversee the review of master and executed batch records, ensuring deficiencies are addressed and appropriate follow-up actions are taken.
- Serve as the QA single point of contact (SPOC) for designated contract manufacturing organizations (CMOs), supporting audits, CAPA management, and the development of quality agreements.
- Contribute to project management activities and actively participate in TRD product portfolio and operational initiatives.
- Support audit and inspection readiness, and provide expert input during these events.
- Provide cover for colleagues within the same area of responsibility when needed.
Key Skills and Requirements:
- Strong knowledge of cGMP and experience in technical development, production, and quality assurance.
- Solid scientific, technical, and regulatory understanding.
- Proven organizational and decision-making skills.
- Ability to analyze and evaluate cGMP compliance effectively.
- Fluency in English is required; German fluency is also required for one role, while it is preferred but not mandatory for the second open role.
- Educational background in a relevant field, such as a Master's degree, is desirable.
If you are having difficulty in applying or if you have any questions, please contact … at ...@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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